Identity
- Trade Name
- • ALAYA Spine Surgical Instrument Kit EUDAMED
- Device Name
- ALAYA Spine Surgical Instruments Kit EUDAMED
- Model / Reference
- SRAI-APP EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08437020847155 EUDAMED
- Basic UDI-DI
- 84370208470001PPEUP9 EUDAMED
- EMDN Code
- L0919 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENT KITS, REUSABLE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- The ALAYA Spine Surgical Instruments Kit is intended to be used with the ALAYA Spine Robotic Assistant and ALAYA Spine Fiducial as surgical instruments to assist during spine surgery for invasive (class IIa) and non-invasive (class Ir) steps of the clinical procedures. ALAYA Spine surgical instruments are designed to provide a precise robotic surgical solution for people with spinal pathologies (vertebral fractures, spinal stenosis and kyphosis, among others) requiring transpedicular screw insertion surgery. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
• ALAYA Spine Surgical Instrument Kit by Cyber Surgery S.L. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 84370208470001PPEUP9 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Cyber Surgery S.L.
- EUDAMED SRN
- ES-PR-000042959
Sources (1)
- EUDAMED 92ef678b-2bb6-4ea8-8b33-10bcfcbadf6e 61 fields · synced Jul 26, 2026